The Government of Canada is leading a global movement to address public health problems, especially HIV/AIDS, tuberculosis, malaria and other epidemics, by introducing changes that will help give developing and least developed countries greater access to low-cost pharmaceutical products.
The proposed changes to the Patent Act and the Food and Drugs Act make Canada the first country to take concrete steps to implement the WTO's recent Declaration on the Trade-Related Aspects of Intellectual Property Rights Agreement and Public Health (Doha Declaration). The legislative changes will make it easier for Canadian pharmaceutical companies to export their products to countries in need.
Under the WTO agreement, member countries may allow patented products to be manufactured under licence by someone other than the patent holder for a limited period of time and in response to a public demand by a country with insufficient pharmaceutical manufacturing capacity.
"These proposed legislative changes are broad, flexible and faithful to what WTO members have spent so long negotiating. We hope that our leading role encourages developed countries around the world to follow suit," said Pierre Pettigrew, Minister for International Trade. "These actions demonstrate Canada's strong commitment to the development objectives set out in the WTO Doha Development Agenda."
"Our goal is to address a pressing humanitarian problem, and we have worked with the two pharmaceutical associations and with non-governmental organizations who provide on-the-ground public health assistance to develop legislation that will be part of the solution," said Allan Rock, Minister of Industry. "At the same time, we recognize the need to respect intellectual property rights, which are critical to the development of new products and therapies in Canada. The input of the industry and non-governmental organizations has been invaluable, and I thank all who have participated in these consultations."
"Canada has one of the most rigorous drug approval systems in place, and as Minister of Health, I am committed to ensuring that the system is used to ensure that the pharmaceutical products sent to less-developed countries meet Canadian safety standards," said Anne McLellan, Minister of Health. "This is an important step in helping other countries fight HIV/AIDS, malaria, tuberculosis and other diseases."
"This is one of the most important steps Canada can take to advance global health and human rights, and we hope to see other G-8 countries following suit," said Bill Graham, Minister of Foreign Affairs. "As United Nations Secretary-General Kofi Annan said last week, our action today could save millions of lives. This is a major breakthrough in the international community's capacity to address not just the prevention of AIDS and other diseases in the world, but also the provision of treatment and access to pharmaceutical products for those in need."
"Nothing disrupts development like the burden of disease," said Whelan, Minister for International Cooperation. "Some of the most powerful things we can do to improve the well-being of people overseas involve changes to how we do things right here in our own country, such as changing our patent and drug legislation."
With legislation now introduced, the Government of Canada will put in place the complementary regulatory frameworks as soon as possible. As the government proceeds, it will continue to actively consult with and engage those who will contribute to the ultimate success of this initiative.